Medical Injury Lawyer Blog : Houston Medical Injury Lawyer & Attorney : Arnold & Itkin Law Firm : Pharmaceutical Injuries, Medical Devices : Texas, Dallas, Fort Worth, San Antonio

You can add yet another medical injury to the long list of risks associated with Avandia – this time it is the increased likelihood of developing an eye disorder called Diabetic Macular Edema (DME). According to studies, people who take a group of anti-diabetes drugs called glitazones, including Avandia, are at a greater risk of contracting the disorder.

Avandia and DME

The research was conducted at the Southern California Permanente Medical Group, and was published in the April issue of the American Journal of Ophthalmology. The study is not the first one suggesting a link between glitazone use and DME, but has confirmed a "modest" association between the two. DME is linked to the accumulation of fluid in the eye and swelling, and may eventually lead to loss of vision.

The study, which was conducted on a total of 996 DME patients, revealed that people who took glitazone-containing drugs, like Avandia, were up to 2.6 times more likely to develop the disorder than those who were not taking the drugs. In fact, the risk of developing DME for glitazone users was up to 68% higher than for non-glitazone users. Avandia contains rosiglitazone, which belongs to the glitazone family.

According to the authors of the study, the safety of a drug is as important is its efficacy in treating a disease. However, current safety evaluations for drugs do not take into account long-term safety because approvals are based on short term clinical drugs. This lack of intensive study could result in the release of a potentially defective pharmaceutical drug into the market. The authors have found enough of a link between DME and glitazone use to advise ophthalmologists treating DME patients to consider glitazone use during diagnosis.

Dangers of Avandia

Recently, a study by the Canadian Medical Association Journal found a link between Avandia and a higher incidence of bone fractures in women. Previous clinical studies have also linked the anti-diabetes drug to chest pain, heart failure, and other heart problems. Medical attorneys have been pursuing lawsuits against GlaxoSmithKline, the company that markets Avandia, for these injuries.

The list of risks associated with Avandia use continues to grow. Eye problems are one of the effects of uncontrolled diabetes which, ironically enough, Avandia is supposed to keep under control. If you are currently taking Avandia, you should consult your doctor about the risks of DME. Your doctor may be able to prescribe a less risky substitute.

If you or a loved one has been injured by the use of Avandia or any other pharmaceutical drug, contact a medical injury attorney at Arnold & Itkin LLP for a free consultation.

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If the prospect of contaminated Heparin and injuries from Avandia were not disturbing enough, an eminent cardiologist has now warned of the danger of a biological threat if the FDA does not get its act together, and fast.

Dr. Steven Nissen, a prominent Cleveland Clinic cardiologist and medical researcher, was one of the first to bring the risk of Avandia injuries caused by Glaxo's anti-diabetes drug into the spotlight. This man has a reputation for being straight forward and honest and has never shied away from calling out pharmaceutical companies and the FDA for their negligence.  He has also been named a possible contender for FDA chief.  Big pharmaceutical companies have always been wary of his announcements and the FDA has frequently been the target of Dr. Nissen's criticism. 

So, when Dr. Nissen raises concerns that terrorist organizations, like Al-Qaeda, could use the FDA's scant oversight of foreign pharmaceutical plants to mount a biological attack on the U.S., we are inclined to pay attention. Dr. Nissen insists that he is not trying to stir up paranoia. Recent instances of the FDA’s somnambular conduct of its drug safety processes, especially at foreign plants, do raise concerns that the facilities could be used by those who seek to harm Americans. China, for instance, is growing to be a significant source of drugs manufactured for Americans. Last year's heparin scandal was traced to batches of contaminated Heparin injections manufactured in China. The Heparin contamination, it is believed, came from adding a synthetic, cheaper compound in place of the original ingredient in a possible effort to cut costs. Since then, we have found that the FDA has not conducted a single inspection of the Chinese plant since it received approval several years ago. The FDA now has an inspection office in China to handle inspections of food and drug plants supplying the U.S. It seems like a reassuring first step, until you realize that the total staff strength at the Chinese FDA office is 8.

The FDA admitted that it has been unable to adapt to growing changes brought about by globalization. In a scenario where a growing number of drugs are sourced from Chinese plants, there may be reason to worry about whether a lack of FDA inspections, combined with poor regulatory standards in China could lead to the first major biological terrorist attack on the U.S. Of course, the chances of terrorists infiltrating a Chinese pharmaceutical plant and contaminating drugs meant for American consumers may seem far fetched now, but we never imagined that a group of zealots would drive aircrafts into the heart of New York City either. 

Medical Injury Lawyers

The FDA's poor oversight of drug makers and poor regulatory practices, combined with pharmaceutical companies' negligence, have time and again placed American consumers at risk of tainted or defective pharmaceutical drugs. If you have been injured as a result of using a dangerous drug or defective medical device, you will need the help of a medical injury lawyer to recover the compensation you deserve.

To get the help you need contact a medical injury lawyer at Arnold & Itkin LLP for a free consultation.

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Under scrutiny for its failure to prevent unsafe pharmaceutical and medical devices from entering the American market, the U.S. Food and Drug Administration has been criticized by a government body in a report filed this week.

The U.S. Government Accountability Office (GAO) expressed doubts that Americans can expect adequate protection “from unsafe and ineffective medical products” from the FDA.  The GAO submitted its list of federal government agencies that are in need of improvement and the FDA made the list, which also includes the Treasury Department and Medicare. According to the report, FDA efforts to ensure the safety of the American consumer have been deterred not only by increasing globalization that has led to a large number of drugs and devices being made in overseas plants, but also because newer and more complex devices are being developed. Already bogged down by a lack of resources to handle such complex and technologically advanced products, the FDA also lacks access to databases that allow thorough and regular inspections of all plants, including the many overseas.  Other groups have also criticized the FDA's record in keeping dangerous drugs and devices out of the American market. The FDA acknowledges that there are holes in the system that need to be plugged if the agency is to be able to carry on its task of protecting American consumers.

Meanwhile, with a new administration in power there are signs that a beefing up of FDA may be in the works. According to another report, House Energy and Commerce Democrats are planning to introduce new laws that give the country's premier drug safety agency greater powers to oversee pharmaceutical drugs and medical devices. Disapproval for the FDA's conduct has spilled over into criticism for just about anything the beleaguered agency does. Earlier in January, a slideshow that attempted to boost morale by comparing the FDA chief Janet Woodcock to Gandhi had lawmakers furious about the $1.5 million contract awarded to the consultant responsible for the creation of the slide show. Another point of criticism was that the slideshow contract was handed to a firm known for its contact with pharmaceutical companies. The FDA has, in recent years, also come under fire for its links to the pharmaceutical industry.

The agency's failure to guarantee the quality of pharmaceutical drugs and medical devices introduced into the market has left dozens of people dead and hundreds injured in recent pharmaceutical scandals. Some of these include Avandia heart injuries, contaminated Heparin and Paxil side effects.  

Medical Injury Lawyer

If you have been injured by the use of a defective pharmaceutical drug or medical device, you will need the representation of an expert medical injury lawyer to recover compensation. 

Contact a medical injury lawyer at Arnold & Itkin LLP for a free consultation.

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A series of e-mails confirm what medical injury lawyers have suspected for months now - that GlaxoSmithKline has been long aware of the side effects associated with the use of its diabetes medication, Avandia.

In 2007, a study by pioneering Cleveland Clinic cardiologist Dr. Steven Nissen, published in the New England Journal of Medicine, revealed that patients who took Avandia are at a higher risk of developing cardiac disease. Doctor Nissen studied the effects of Avandia use in more than 15,000 patients, monitoring 12,283 subjects in a control group. He found 86 cases of myocardial infarction in the group that was given Avandia, compared to 72 cases in the control group, and 39 deaths among Avandia users as opposed to 22 deaths in the control group. At the time, Dr. Nissen acknowledged that a few deaths in more than 15 thousand subjects may seem like an inconsequential number, but because the studies were conducted over a short period of time and because of the increased risk of heart disease in diabetic patients, the enhanced incidence of heart attacks in Avandia users was cause for worry. Glaxo was quick to refute the findings of the study. The company released a statement questioning the methods used by Dr. Nissen, but the FDA quickly issued a safety alert on Avandia.

Since then, the link between Avandia and heart disease has become stronger with more numbers of people killed and hundred of cases of heart failure. Now, reports indicate that the company was aware of the increased risk all along. According to reports, senior GlaxoSmithKline scientists wrote e-mails just before the publication of Doctor Nissan's study admitting that his findings were "very similar" to the conclusions reached by GlaxoSmithKline. The company, at the time, was under scrutiny because of the Vioxx scandal which associated Merck's painkiller with an increased risk of heart disease. The Vioxx concerns ended with the company withdrawing the drug and hundreds of medical injury lawsuits filed by patients who suffered heart attacks after taking Vioxx.  Desperate to avoid Merck's fate, Glaxo went all out to criticize Dr. Nissen's findings almost immediately after publication of the study. Avandia use has decreased dramatically since then, but it remains on the market and thousands of patients continue to take the drug.

Pursuing Medical Injury Claims

Pharmaceutical companies may often hide important safety information about their drugs in order to remove obstacles in their marketing plan. Such suppression of information may be grounds for a medical injury lawsuit against the drug maker in the event of injuries caused by the drug.

If you or a loved one have suffered heart problems after taking Avandia, you may have grounds for compensation. Contact the medical injury lawyers at Arnold & Itkin LLP for a free evaluation of your case.

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A study published by the Canadian Medical Association Journal reveals that female patients who take Glaxo SmithKline's type 2 diabetes drug Avandia have an incidence of bone fractures that's twice the rate of men with diabetes who are on the medication. 

The study was based on the findings of 10 clinical trials conducted on nearly 14,000 patients. Researchers at the Wake Forest University School of Medicine found that out of every 20 women in their seventies with type 2 diabetes who took Avandia for a minimum of one year, there was at least one incidence of bone fracture. The risk for women in their fifties was one bone fracture per 55 women. In both these cases, the figure is almost twice the acceptable risk for those age groups.

Avandia is part of the thiazolidinedione group of drugs or glitizones that are used to lower blood sugar levels in people who suffer from type 2 diabetes.  This group of drugs has already been linked to cardiovascular problems including accelerated heart rate, heart failure and cardiac arrest. The FDA requires that Glaxo SmithKline post strong warning labels on Avandia containers warning about these risks. These additional findings that point to an increased risk of bone injuries in patients who take Avandia are bound to disturb female patients. As women age, they are more predisposed to bone fractures, regardless of whether they suffer from diabetes or not, and Avandia's increased bone fracture risk has medical experts wondering if the drug's blood sugar level lowering benefits are really worth the multiple risks that the medication comes with.

Avandia and Heart Problems

Clinical studies have shown an increased risk of heart-related problems including heart failure and chest pain with patients who take Avandia. Patients are encouraged to speak with their doctor regarding the risks and side effects of Avandia, and weigh the risks with the benefits before making a decision to take the medication.

Patients who have suffered health problems as a result of taking Avandia have filed lawsuits against Glaxo SmithKline for its failure to report the cardiac risks associated with use of the drug. The company has a poor record of safety reporting, and has been embroiled in legal battles regarding its failure to make public safety test results of its anti depressant Paxil, and its dangerous side effects on unborn fetuses. Paxil has been linked to serious birth defects including atrial septal heart defects, PPHN, and congenital defects Omphalocele and Craniosynostosis.

Avandia Injury Lawsuits

If you or a loved one has suffered cardiovascular problems or bone fracture injuries after taking Avandia, you may be able to obtain compensation for your injuries with the help of a medical injury lawyer. The lawyers at Arnold & Itkin LLP have years of experience in drug injury litigation, and have the expertise and resources to pursue claims against big pharmaceutical companies like Glaxo SmithKline.

Contact an experienced medical injury lawyer at Arnold & Itkin LLP for a free evaluation of your claim.

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